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Document 52012SC0437
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT
/* SWD/2012/0437 final */
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT /* SWD/2012/0437 final */
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document revision of Council Directive
96/98/EC of 20 December 1996 on marine equipment Lead DG: DG
MOVE Executive summary 1. Problem definition Experience with the working of the Marine
Equipment Directive (hereinafter referred to as "MED") highlighted
certain implementation and enforcement weaknesses, mostly as regards: the
quality and control of the work of the notified bodies (organisations carrying
out conformity assessment procedures on the Member States' behalf); the
obligations of the economic operators; the effectiveness of market surveillance
activities; the safeguard mechanisms (which ensure that Member States take
measures against non-compliant equipment, and that these measures are
controlled in order to ensure that they do not constitute disguised obstacles
to the free movement). Given that the legislative technique used
in MED to achieve its policy objectives is largely based on the principles
defined in the New Approach[1]
for the area of free movement of goods, the implementation and enforcement
issues identified above are shared with all New Approach Directives. To correct the malfunctions of the system, the
New Approach was subject to a revision in 2008 which led to the New
Legislative Framework (hereinafter the "NLF") for the marketing
of products.[2] Therefore, the problems identified for the
MED can be addressed by aligning the MED on the NLF as foreseen by the
co-legislators. However, in light of the specificities of the marine equipment,
a key issue is whether MED-specific solutions are also needed in some areas.
The impact assessment provides a detailed mapping of the NLF against MED
specificities. Among these: ·
Marine equipment must comply with the
construction and performance requirements, and be tested in accordance with the
testing standards, laid down by the IMO; ·
Marine equipment must be approved by the flag
State; ·
Marine equipment is not necessarily marketed in
EU territory, but it is rather installed directly on board EU ships wherever
these are built or repaired, or take supplies; ·
Marine equipment includes many items which fall
under the scope of other Internal Market directives, however the requirements
of these are different from or incompatible with those of the IMO. ·
In addition, the transposition process of IMO
rules into national law creates legal uncertainty and imposes excessive burden
upon the industry and national administrations because of a long and complex
legislative technique – making it very difficult to keep up with the production
of technical requirements by the International Maritime Organisation. For these reasons, the MED does not ensure
the complete application and implementation of IMO and other standards by
Member States, leading to safety risks and inefficient functioning of the
Internal Market for marine equipment. Stakeholders affected include European
marine equipment manufacturers, among which a large number of SMEs, shipyards,
ship passengers and crews, as well as public administrations and governments. 2. Analysis of subsidiarity and
proportionality Direct application of the IMO regulatory
framework by the Member States in the absence of Community harmonisation would
lead to barriers to the free movement of goods, mostly stemming from a) the
broad discretion left by the IMO instruments to the flag state, b) the
production of additional national requirements and c) the divergences in the
certification methods. At the same time, the resulting divergences in national
regulations would lead to uneven degrees of safety and environmental
protection. Harmonisation by the EU resolves these
problems, as it results in a clearly identified set of requirements and uniform
certification procedures capable of ensuring a high level of safety and of
environmental protection. Moreover, unlike the international system, the EU
offers the advantage of a judicial enforcement system – without which the
effectiveness of those requirements and procedures would be seriously
undermined. The EU does not harmonise itself the
detailed technical specifications applicable, which are decided at the IMO
level with full contribution of the Member States. It merely identifies in a
clear way what specifications and technical standards of the IMO should be
applied. 3. Objectives of the EU initiative 3.1. General
objectives Pursuant to Articles 90 and 91 TFEU, the
Common Transport Policy (CTP) should contribute to the broader objectives of
the Treaties. Within the framework of CTP and taking into account the specificities
of marine equipment, the general objective of the proposed initiative is
twofold: ·
to enhance the implementation and enforcement
mechanisms of the MED, thereby guaranteeing the proper functioning of the
internal market for marine equipment while ensuring a high level of safety at
sea and prevention of marine pollution; ·
to simplify the regulatory environment while
guaranteeing that IMO requirements are applied and implemented in a harmonised
way across the EU, thereby contributing to ensuring that the conditions
necessary for the competitiveness of the Union's industry exist pursuant to
Article 173 TFEU. 3.2. Specific
objectives Based on the problem and related root
causes set out in section 2 above, the twofold general objective can be translated
into more specific objectives: ·
to find an optimal way to align MED on the New
Legislative Framework (as required under Article 2 of Decision 768/2008/EC (the
NLF Decision) while taking due account of the specificities of marine equipment
in the field of market surveillance, conformity assessment of products and
obligations of actors in the distribution chain. ·
to shorten, simplify and clarify the
transposition of amendments to IMO standards into the European and national
legal frameworks. 4. Policy options The Commission has identified four policy options – besides the
baseline scenario. All policy options have been designed to be able to address
both specific objectives defined in section 3. The
Commission performed a preliminary assessment of the 4 possible policy options
on the basis of their effectiveness in addressing current problem drivers and
of their efficiency. In parallel, the coherence of the possible policy options
with the principles of subsidiarity and proportionality has been assessed. As a
result of this pre-screening, 2 policy options, besides the baseline scenario,
have been retained for in-depth assessment. Policy Option 2 would foresee a maximum alignment of the MED on the
NLF, where departure from the latter's provisions would be kept to those issues
where it is considered indispensable in any case – namely specific marking. Policy Option 3 would take the form of a conditional alignment of
the MED on the NLF, where additional MED-specific solutions would be introduced
to optimise the effectiveness of the instrument, namely in the areas of IMO
requirements and standards, obligations of economic operators, use of
conformity assessment modules, product traceability and safeguard clause. These
areas would largely be the same where the MED currently departs from the New
Approach. Table 1: Description of retained Policy Options || Policy Option 2 maximal alignment to NLF || Policy Option 3 conditional alignment to NLF · Specific Objective 1: to find an optimal way to align MED on the NLF while taking into account the specificities of marine equipment Market surveillance || || Common EU framework || Word by word transposition of NLF provisions into MED || · Same as PO2 More effective post-market control mechanism || Word by word transposition of NLF provisions into MED || · Same as PO 2 + Introduction of the possibility to use electronic tags to give better tools to market surveillance for detecting non-conforming equipment. Safeguard clause procedure || Word by word transposition of NLF provisions into MED || · Same as PO 2 + Additional provisions adapting the administration of the safeguard clause, making it possible for the Commission to decide to limit its assessment to the respect of due procedure by the Member State concerned. Conformity assessment of products || || Essential requirements || Word by word transposition of NLF provisions into MED - current annexes to MED to be abandoned; compliance with IMO requirements[3] turned into "essential requirement". || · Mandatory technical norms including mandatory and non-mandatory IMO requirements as well as European and international testing standards developed by European and international standardisation organisations on the basis of the IMO requirements. Notification of conformity assessment bodies || Word by word transposition of NLF provisions into MED || · Same as PO2 Conformity assessment procedures || Word by word transposition of NLF provisions into MED || · Selective use of conformity assessment modules, whereby notably modules A and C (corresponding to the possibility of conformity assessment of products by in-house Notified Bodies) are not retained. CE marking || No alignment, CE marking replaced by a wheelmark || · No alignment, CE marking replaced by a wheelmark Toolbox of measures for use in legislation || || Obligations of actors in the distribution chain || Word by word transposition of NLF provisions into MED || · Adaption of obligations of actors in the distribution chain, reflecting the irrelevance of concentrating on the small share of marine equipment which is actually placed on the market within the EU territory. · Manufacturers: same as in PO2 · Importers and distributors: identification and registration; cooperation with market surveillance authorities (information, documentation, removal of risks, etc.) Harmonised definitions and procedures (save the CE marking) || Word by word transposition of NLF provisions into MED || · Same as in PO2. · Specific Objective 2: to simplify, clarify and shorten the transposition of amendments to IMO standards into the European and national legal frameworks -/- || No transposition into EU legal order; IMO requirements in the form of essential requirements directly applicable in Member States. International and European standards are optional and give presumption of conformity. || · Transposition of IMO requirements through implementing or delegated Regulations, which do not require transposition into national legislations. Testing standards (whether developed by IMO or by standardisation bodies) are mandatory. 5. Assessment of impacts The following table presents an aggregated
qualitative assessment of of the expected economic, social and environmental
impacts. Table 2: Qualitative assessment of the expected
impacts of PO2 and PO3 || Policy Option 2 || Policy Option 3 Economic impacts || || Internal market || || Common EU framework || ++ || ++ More effective post-market control mechanism || ++ || +++ Safeguard clause procedure || ++ || +++ Conformity assessment of products || ++ || +++ Obligations for actors in the distribution chain || - || ++ Harmonised definitions || = || = Uniform interpretation and implementation of IMO requirements || -- || = Operating costs and administrative burden || || Economic operators || ++ || +++ Notified bodies || = || = SMEs || + || ++ Competitiveness of economic operators || || Enforcement system || ++ || +++ Traceability of products || + || ++ Obligations of actors in the distribution chain || - || = Conformity assessment || ++ || +++ Public authorities || = || ++ Users and passengers || = || = Third countries and international relations || = || = Social impacts || || Safety || ++ || +++ Environmental pollution || || Marine pollution || ++ || +++ Simplification of the regulatory environment || + || +++ Legend: = baseline
or equivalent to the baseline + to +++ low
to high improvement compared to the baseline - to - - - low
to high worsening compared to the baseline When compared with the baseline, both
policy options have turned out to bring about positive impacts in most cases,
particularly as regards the effectiveness of the control and enforcement
mechanisms (notified bodies, market surveillance, safeguard clause). As a result
of this, both policy options would on the whole result on more safety and
better protection of the marine environment. The current system to transpose
the IMO requirements into national legal orders would in both cases benefit
from faster and more efficient mechanisms, centralised in the case of PO3 and
left entirely to the Member States in the case of PO2. However, PO2 has two important drawbacks.
In the first place, replacing the current Directive's annexes by a generic
requirement of compliance with the relevant international technical
requirements and testing standards would in the long term negatively affect the
smooth functioning of the internal market, as differences between Member States
would inevitably build over time; this would also affect safety, as not all
Member States would implement the latest requirements punctually, while the
many valuable non-mandatory instruments produced by the IMO would be completely
left aside. Secondly, an alignment of the obligations of economic operators on
the NLF would result in an additional, disproportionate burden mainly for
importers and distributors: these actors, who are only relevant for the small
fraction of equipment which is imported into EU territory, would nevertheless
have to put in place an administrative structure which does not exist today and
the benefits of which would not accrue to a majority of the products covered by
the Directive – which are directly installed on board EU ships in ship building
and repair yards, mostly outside the EU territory. In contrast, PO3, thanks to its
MED-specific solutions which are selectively adapted to the particular features
of the marine equipment sector, proves more advantageous in several areas: ·
The use of implementing or delegated regulations
instead of the current Directive annexes provides a mechanism which is as fast
as the solution envisaged under PO2, but without the above mentioned drawbacks
for the Internal Market as the applicable requirements would remain fully
harmonised at all times; moreover this system provides greater legal certainty
for the operators and is cheaper for public administrations; ·
Conformity checking improves thanks to the clear
identification of testing standards, while the implementation of IMO
non-mandatory instruments gives PO3 a clear edge in terms of safety; ·
The possibility to use electronic tags improves
the effectiveness of market surveillance and helps protect the manufacturers'
IPR at a negligible cost; ·
Better adapted obligations for economic
operators removes unnecessary burdens; ·
A simpler, faster safeguard clause mechanism
removes unnecessary economic and reputational costs for compliant
manufacturers. 6. Comparison of options In terms of effectiveness, the
specific measures contained in PO3 allow the MED to better serve the general
objective of guaranteeing the proper functioning of the internal market for
marine equipment while ensuring a high level of safety at sea and prevention of
marine pollution, by better adapting to the particular features of the sector.
This is mainly the case of the strengthened enforcement and control mechanisms
(better market surveillance, simplified safeguard clause) and a system that
ensures that all relevant IMO requirements (mandatory or not) as well as
international and European standards are implemented within the EU in a
harmonised way. In addition, PO3 eliminates the most burdensome and confusing
need to transpose amendments into the 27 legal systems of the Member States,
while PO2 leaves it untouched. For this reason, PO3 should be preferred over
PO2. As regards efficiency, PO3 offers solutions at less costs and administrative burden for the
different stakeholders than in PO2, along with a stronger beneficial effect on
competitiveness (particularly as regards SME's). PO3 therefore emerges as the
most efficient course of action. As regards coherence with the overarching
EU objectives, strategies and priorities, whereas both policy options would
bring about improvements in terms of maritime safety and protection of the
marine environment, and simplified legal framework, the best results should be
expected from PO3, while PO2 might not be able to deliver in terms of smooth
functioning of the internal market. Table 3: Comparison of Policy Options || Effectiveness || Efficiency || Coherence Baseline || no || no || no Policy Option 2 || low || low || medium Policy Option3 || high || high || high In light of the above, PO3 overall rates
better than PO2 and is therefore the preferred option. 7. Monitoring and evaluation Once aligned with the new regulatory
framework for the marketing of products, the MED will fully benefit from the
latter's monitoring and evaluation mechanism. Specific measures have been envisaged
in addition to the alignment in order to verify the effectiveness of the action
and gather feedback from the stakeholders such as: ·
As a result of the reform more informative data
will be obtained from the market surveillance activities as well as from port
state control. EMSA will continue to refine the production of statistics on the
implementation of the directive and to organise workshops for technical
discussion and training activities with the Member States.. ·
Contacts with the industry will continue including
workshops on the implementation of the amended MED. ·
Enhancing the activities of the MARED Group of
notified bodies. ·
Finally, an ex-post evaluation will be organised
within [5 years] of the entry into force of the new system. [1] For a description of the New Approach and its
associated problems, see the Commission's Impact assessment on the proposal for
a Regulation setting out the requirements for accreditation and market
surveillance relating to the marketing of products and a Decision on a common
framework for the marketing of products, SEC 2007(173). [2] Annex 7 of the present impact assessment contains a
description of the elements of the NLF. [3] Consequently, non-mandatory requirements,
recommendations and guidelines would not be covered by this essential
requirement.